EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Equate Childrens Multi symptom Cold Nighttime by

Drug Labeling and Warnings

Equate Childrens Multi symptom Cold Nighttime by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenyephrine HCl 5 mg

PURPOSE

Pain reliever / fever reducer

Antihistamine/Cough Suppressant

Nasal decongestant

USE(S)

temporarily relieves these common cold and flu symptoms:

• cough 
• sore throat
• nasal congestion
• runny nose
• minor aches and pains
• headache
• sinus congestion and pressure
• sneezing
• temporarily reduces fever
• controls cough to help your child get to sleep

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes 

• more than 5 doses in 24 hous, which is the maximum daily amount
• with other drugs containing acetaminophen.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. 

DO NOT USE

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on the skin.
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

ASK A DOCTOR BEFORE USE IF THE CHILD HAS

• liver disease
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• glaucoma
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD 

• is taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

WHEN USING THIS PRODUCT

• do not use more than directed (see Overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase dowsiness

STOP USE AND ASK DOCTOR IF

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

DIRECTIONS

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• shake well before use
• do not give more than 5 doses in any 24-hour period
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter
• Children 6 to under 12 years of age: 10 mL in dosing cup provided.
• Children under 6 years of age: do not use.

OTHER INFORMATION

• each 10 mL contains: sodium 10 mg
• store between 15-30°C (59-86°F)
• do not refrigerate
• dosing cup provided

INACTIVE INGREDIENTS

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

QUESTIONS OR COMMENTS

1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-623-03

equate

Compare to Children's Mucinex® Nighttime Multi-Symptom Cold active ingredients*

Children's Multi-Symptom Cold 
NIGHTTIME

Acetaminophen 325 mg
Pain reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg

Antihistamine/Cough Suppressant 

Phenylephrine HCl 5 mg

Nasal Decongestant

AGES 6 to 12 YEARS

• Reduces headache and fever
• Relieves nasal congestion
• Soothes Cough 
• Relieves runny nose and sneezing

Mixed Berry Flavored

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-623
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-623-03	1 in 1 CARTON	08/01/2017
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/01/2017

Labeler - Wal-Mart Stores, Inc. (051957769)